Belgium Notified Draft Royal Order on Nano-Substances to the EC
Belgium recently notified the European Commission (EC) of its draft Royal Order on the marketing of substances manufactured to nano-particle scale (notification number 2013/369/B). The Draft Royal Order proposes:
- A declaration requirement in Belgium for substances manufactured at nano-scale, and placed on the market as such, and for preparations containing substances manufactured at nano-scale; and
- A notification requirement for articles, complex objects, or categories of complex objects incorporating substances manufactured at nano-scale.
Scope of the Order
The Draft Royal Order is similar in many respects to the adopted French legislation on nano-declaration requirements (discussed in detail in the PackagingLaw.com article titled, Engineered Nanosubstances: France to Require Annual Declarations). One significant difference between the Belgian Draft Royal Order and the corresponding French legislation is that materials and articles intended to come into contact with foodstuffs are explicitly excluded from the scope of the Belgian Draft Royal Order. Aside from food-contact materials and articles, many other products are excluded from the scope of the Draft Royal Order, including, but not limited to:
- Foodstuffs as referenced in the Belgian Law of January 24, 1977, and feedstuffs as defined by Regulation (EC) No 178/2002 laying down the general principles and requirements of food law;
- Cosmetics as defined pursuant to the Cosmetics Regulation (EC) No 1223/2009;
- Biocidal products and treated articles falling within the scope of the Biocidal Products Regulation (EU) No 528/2012; and
- Medicines intended for human and veterinary use falling within the scope of Regulation (EC) No 726/2004 on the EU authorization and supervision of medicinal products for human and veterinary use and the Belgian Royal Order of December 14, 2006.
The First Chapter of the Draft Royal Order outlines a number of important definitions. In particular, Article 1.7 defines a "substance manufactured at the nano-scale" using, as a starting point, the EC's Recommendation dated October 18, 2011, on the definition of nano-material (2011/696/EU). However, one important respect in which the Draft Royal Order differs from the EC's Recommendation is that the Draft Royal Order excludes from its scope "chemically unmodified natural substances, accidentally produced substances and substances whose fraction between one nanometre and one hundred nanometres is a by-product of human activity." In this respect, the Draft Royal Order is more similar to the corresponding French legislation that only applies to substances "intentionally manufactured to a nanometric scale."
Article 1.8 of the Belgium Draft Royal Order defines a natural substance as "a naturally occurring substance, as such, unprocessed, or processed only by manual or gravitational means, dissolving in water, flotation, extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from the air by any means."
Pursuant to Article 1.9 of the Draft Royal Order, a by-product of human activity is "a substance derived from an activity or production process whose primary objective is not the production of the substance." It adds that the following shall not be considered to be by-products of any human activity:
- "Substances produced as the result of a technical choice;"
- "Substances which are not necessary for the production of the main product;" and
- "Substances whose specific technical characteristics are the result of voluntary changes to the production process."
Declaration of Substances Versus Notification of Articles and Complex Objects
The Draft Royal Order distinguishes between the declaration of substances manufactured at nano-scale and preparations containing a substance or substances at nano-scale on the one hand (in Chapter II) and notification of articles and complex objects incorporating one or more substances manufactured at the nano-scale on the other hand (in Chapter III).
Pursuant to the Draft Royal Order, the person responsible for the placing on the market of substances manufactured to a nano-scale as such or in a preparation must submit a declaration to the Belgian authorities before placing them on the market if: 1) 100 grams or more of the substance is placed on the market over the relevant period; and 2) the substance or the preparation containing it is produced by the person placing it on the market or is marketed exclusively to professional users. If one or more substances are placed on the market in a preparation, then the preparation would need to be declared.
The declaration of substance(s) manufactured at the nano-scale or in mixtures must include: the identification of the person submitting the declaration, the substance at stake, and the quantity and use of the substance and professional users to whom it is supplied (see Annex I). If several nano-substances are included in a preparation, a declaration must be submitted with the data outlined in Annex II.
The Draft Royal Order requires notification of articles and complex objects incorporating a substance or substances manufactured at nano-scale, if:
- More than 100 grams of one or more of these substances is placed on the market during a calendar year;
- The article or complex object may, under reasonably use, discharge more than 0.1% of the initial mass of any of the substances manufactured at the nano-scale in the article; and
- The article or complex object is produced by the person placing it on the market or is placed on the market exclusively for professional users.
The notification for articles and complex objects containing nano-substances falling within the scope of the Draft Royal Order must include: the identification of the person submitting the declaration, the concerned articles and complex materials, and the substances manufactured to a nano-particle scale (see Annex V).
Now that the Draft Royal Order has been notified to the EC, the Commission and Member States may submit comments on it during the three month "standstill" period that will expire on October 7, 2013. If the Commission or Member States object to the Draft Royal Order, the standstill period will be extended for three months. Belgium may not take steps to adopt the Draft Royal Order until the standstill period ends.
According to the current text of the Draft Royal Order, the declaration requirement for substances manufactured at nano-scale and placed on the market as such will become effective January 1, 2015. The declaration requirement for preparations containing substances manufactured at nano-scale, and the notification requirement for articles, complex objects, or categories of complex objects incorporating substances manufactured at nano-scale will become effective January 1, 2016.